Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Crossing Over the Thin Blue Line: Increasing Access to Pregnancy Tests
Webinar
FHI 360 & Marie Stopes International Innovation Fund Project—Reproductive Health Supplies Coalition January 14, 2016
Background & Rationale
Webinar
Dr. John Stanback
3
Ruling out pregnancy
“She can start ____ immediately if it is reasonably certain that she is not pregnant.”WHO “Selected Practice Recommendations for Contraceptive Use,” 2nd Ed. 2004
4
An ongoing medical barrier
• Nearly half of new family planning clients are not menstruating when they visit the clinic
• Non-menstruating women are routinely denied family planning services
• May be a particular issue with access to LARCs
Few non-menstruating clients are actually pregnant
According to WHO, no known harm occurs to either a pregnant woman or a fetus from exposure to hormonal family
planning methods*
*In case of the IUD, it is very important to rule out pregnancy because inserting an IUD in a woman who is already pregnant may result in septic miscarriage, which is a serious complication.
5
Partial Solution: The Pregnancy Checklist
• Research demonstrates that the checklist is effective at ruling out pregnancy
• Included in the Global Handbook for Family Planning and in the WHO Decision-Making tool
• Some providers don’t like/ trust the checklist
• Instances when the checklist cannot exclude pregnancy
6
Pregnancy tests available for purchase for ≤ US$0.10
7
Research in Zambia (FHI 360)
1517
4
17
0
10
20
30
Free Pregnancy Tests Control
Pre-testPost-test
% New, Non-Menstruating Clients Denied Effective Method
Stanback et al. Does free pregnancy testing reduce service denial in family planning clinics? A cluster-randomized experiment in Zambia and Ghana. Global Health: Sci Practice. 2013 Sep 24;1(3):382-8. doi: 10.9745/GHSP-D-13-00011. eCollection 2013.
8
Additional potential benefits
FP demand generationSocial marketingTool for improving continuation of
progestin-only methodsContribute to decrease in gestational
age for clients seeking ANC and abortion services
9
When should a pregnancy test be used?
• E.g., for women presenting between menses?• Misuse is common• Official guidance can be confusing, contradictory
10
Proposed Clinical Guidance: When to use the Checklist vs. Pregnancy Test
Hormonal Methods Intrauterine Devices (IUDs)
Amenorrhea Take history using pregnancy checklist. • If pregnancy ruled out, provide method.• If pregnancy not ruled out, use pregnancy test if
available. • If the test is negative (or not available), provide the
method, but schedule a follow-up pregnancy test in 3-4 weeks.
Take history using pregnancy checklist. • If pregnancy ruled out, provide method.• If pregnancy not ruled out, a pregnancy test
should be used. If negative, advise woman to use a barrier method or abstain for 3-4 weeks, then repeat pregnancy test.
• If the test is still negative, provide an IUD.
Between Menses
Do not use pregnancy test (it is too early for it to be effective).
Take history using pregnancy checklist. • If pregnancy ruled out, provide method.• If pregnancy not ruled out, do not provide implant,
but “Quick Start” (explained below) is acceptable for pills and injectables (pregnancy assessment recommended if next menses are delayed).
Do not use pregnancy test (it is too early for it to be effective).
Take history using pregnancy checklist. • If pregnancy ruled out, provide method.• If pregnancy not ruled out, do not provide IUD.
Advise woman to use barrier method or abstain and return for IUD insertion within 12 days of onset of next menses.
Missed Period History not necessary; use pregnancy test.• If using highly sensitive pregnancy test (e.g., 25 mIU/ml) and it is negative, provide desired method. • If using test with lower sensitivity (e.g., 50 mIU/ml) and it is negative, wait and reassess at least 10 days after
expected date of menses. If test is still negative, provide desired method.
SHOPS is funded by the U.S. Agency for International Development.Abt Associates leads the project in collaboration withBanyan GlobalJhpiegoMarie Stopes InternationalMonitor GroupO’Hanlon Health Consulting
Impact of Free Pregnancy Test Kits on Contraceptive Distribution: Evidence from an Experiment in MadagascarAlison Comfort, Ph.D.(co-authors Slavea Chankova, Randall Juras, Natasha Hsi, Lauren Peterson, and Payal Hathi)Abt Associates
Reproductive Health Supplies Coalition - WebinarJanuary 14, 2016
Background
2
Contraceptive provision by CHWs
• There remains significant unmet demand for contraceptives in sub-Saharan Africa (SSA)
• Contraceptive provision has been shifted to community health workers (CHWs) to improve access, particularly in remote and rural areas
• CHWs are trained to provide oral and injectable contraceptives• Most popular forms of contraceptives in SSA• Sell hormonal contraceptives at a small profit 3
Barrier to selling hormonal contraceptives
• WHO recommends that health workers confirm that a woman is not pregnant before offering hormonal contraceptives
• CHW have been trained to rule out pregnancy using a pregnancy checklist
4
• Challenges with checklist:• Some women categorized as “could be pregnant” but are not• CHW may not trust the woman’s responses
• CHWs used checklist but only 46% viewed it as reliable
Intervention
• Provide CHWs pregnancy test kits to distribute for free
• Benefits of pregnancy tests:• Easy to administer• False positive are highly unlikely• Increasingly affordable
5
(Cypress Diagnostics hCG Dipstrip)
• Intervention could increase contraceptive distribution by:• Improving access: CHWs use test as complement to
checklist• Generating interest in FP: Women want to know
pregnancy status, resulting in FP counseling
Research question
• Does providing CHWs with pregnancy test kits increase the number of new hormonal contraceptives clients per CHW?
• Outcome of interest• Number of new hormonal
contraceptive clients per CHW
6
Alison C
omfort
Study Methodology
7
Study participants
8
Regions
• All CHWs supported by the Santénet2 project and trained in selling oral and injectable contraceptives
• Study participants = 622 CHWs
(CHW showing examples of FP methods)Atsinanana
Aloatra Mangoro
Analanjirofo
Study design: randomized experiment
Treatment group Control group
Given free pregnancy test kits+
Training on how to use them
272 CHWs
9
No free pregnancy test kits+
No training on kits
263 CHWs
Baseline: characteristics of CHWs
10
David D
ennis
(CHW speaking with client)
• Most CHWs are women• 5th grade level of education• Live 2 hours from nearest
health center• Have 39 FP clients
Resultsand
Policy Implications
11
26% increase in number of new hormonal contraceptive clients per CHW per month
12
3.1
2.5
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
Treatment Group Control Group
New hormonal contraceptive clients
Treatment GroupControl Group
Difference = 0.7**which represents a 26% increase
** indicates that the difference is statistically significant at the 95% level (p<0.05)
Policy implications
• Intervention is an effective approach to increase distribution of contraceptives in countries like Madagascar
• Pregnancy tests should be included as a low cost addition to community-based distribution programs
• Based on the results of our study, Ministry of Health in Madagascar decided to scale-up distribution of free pregnancy test kits
13
Full study available in Contraception (2016)
Scale-up of intervention
15
Scale-up of intervention
• Pregnancy test kits were added to the essential medicines list in Madagascar
• Created a Technical Working Group with key stakeholders
• USAID procured pregnancy test kits• Total of 700,000 procured• In our sample, CHWs distributed 7 tests/month
• Being distributed by social marketing organization (PSI)
• MIKOLO project, 5-year USAID project, is leading the scale-up• Training CHWs to incorporate these tests in their work
16
Training of CHWs to provide pregnancy tests
• MIKOLO trained a total of 3,146 CHWs as of August 2015
• Integrate training on pregnancy tests kits into refresher training on FP
• CHWs are trained to use the test as a complement to checklist
• Collecting monitoring data on number of new FP users and antenatal care referrals
17
Preliminary results from scale-up
• New contraceptive clients was 6,500 once pregnancy tests were available, compared to 4,500 in previous months (45% increase)
• Anecdotal evidence that CHWs like using the tests because it facilitates their work
• Challenges:• Some CHWs have incorporated use of test more rapidly/easily than
others• Lack access to supplies such as gloves and sterile cups• Waste management (e.g. cups, gloves, tests)
18
SHOPS is funded by the U.S. Agency for International Development.Abt Associates leads the project in collaboration withBanyan GlobalJhpiegoMarie Stopes InternationalMonitor GroupO’Hanlon Health Consulting
Thank you
For additional comments: [email protected]
SHOPS is funded by the U.S. Agency for International Development.Abt Associates leads the project in collaboration withBanyan GlobalJhpiegoMarie Stopes InternationalMonitor GroupO’Hanlon Health Consulting
Extra slides
Number of study participants
4 trainings
76 CHW intervention
311 CHWs invited to training
3 trainings
56 CHW intervention21
Treatment group Control group
279 CHWs attended training
… and 272 completedbaseline survey
No-show rate: 10%
…and not complete baseline data: 13%
311 CHWs invited to training
266 CHWs attended training
No-show rate: 14%
… and 263 completedbaseline survey
…and not complete baseline data: 15%
Analytical approach
22
𝑦𝑦𝑖𝑖𝑖𝑖𝑖𝑖 = 𝛼𝛼 + 𝛽𝛽 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑖𝑖 + 𝛾𝛾𝛾𝛾𝑖𝑖 + 𝜏𝜏𝑖𝑖 + 𝛿𝛿𝑖𝑖 + 𝜀𝜀𝑖𝑖𝑖𝑖𝑖𝑖
Using an ordinary least squares regression model with month fixed effects, we estimated:
for CHW i in district 𝑑𝑑 at time t.
Variables Definitions
𝑦𝑦 Number of new hormonal contraceptive clients𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 Dummy variable for whether CHW given free pregnancy test kits
𝛾𝛾 Vector of CHWs’ baseline characteristics𝜏𝜏 Month fixed effect𝛿𝛿 District fixed effect𝜀𝜀 Random error
We cluster the standard errors at the CHW level.
29% increase in number of new injectable clients per CHW per month
23
1.9
1.2
1.5
1
0.0
0.5
1.0
1.5
2.0
2.5
New injectable clients New oral contraceptive clients
Treatment Group
Control Group
Difference = 0.4**which represents a 29% increase
** indicates that the difference is statistically significant at the 95% level (p<0.05)Any inconsistencies are due to rounding.
New injectable and oral contraceptive clients
Limitations of the study
• Unable to distinguish the underlying mechanism• Used self-monitoring data
• Non-response: 38% of total reports not submitted• However, results are robust when including non-
response weights to weight up to experimental sample
24
Hypothesized chain of causality
25
CHWs are offered pregnancy test kits to distribute for free + training on how to use these kits
CHWs use tests to check whether women who want
contraceptives are pregnant
Women who want to check whether they are pregnant approach CHWs for the tests
1. CHWs use test kits (instead ofpregnancy checklist) for all newclients who want contraceptives
or
2. CHWs use test kits only forwomen whom the checklistcategorizes as “could bepregnant”
CHWs provide free tests and use this opportunity to also provide FP counseling
Women with negative pregnancy test results become new contraceptive clients of CHWs
Some women who are not pregnant decide to take up contraceptives
Intervention and evaluation timeline
26
CHWs invited to trainings
(baseline data collection and pregnancy test
distribution)
Trainings heldBaseline survey
CHWs distribute pregnancy tests and submit monthly monitoring forms
(4 months after training for each CHW)
Follow-up: study data collection
Mar Apr May Jun Jul Aug Sept Oct Nov
2013
Trainings
27
Treatment group
1. Invited to the training-Filled baseline data survey-Trained on reporting forms
2. Trained on pregnancy test kits
3. Given pregnancy test kits to distribute for free• 50 kits per CHW
Control group
1. Invited to the training-Filled baseline data survey-Trained on reporting forms
Baseline: CHWs’ contraceptive clients
Total clients purchasingFP from CHWs
Injectables 24.0Oral contraceptives 13.7Condoms/spermicides 0.5Standard days methods/cycle beads 0.9
All contraceptives 39.2
28
Innovation Fund Project: Kenya, Malawi and Mali
Webinar
Kate H. Rademacher
2
Project team • Tracey Brett• Mohamed Patrice Diallo• Mahamadou Haddau• Elena Lebetkin• Mario Mame• Mary Mittochi• John Mwaiseghe• Kate Rademacher• Kathleen Ridgeway• Marsden Solomon • John Stanback
Project Goal: • Better understand the current
availability and affordability of pregnancy tests in three countries
• First systematic analysis that has been conducted in this area to date of which we are aware
• Work will guide future assessments, scale-up and advocacy work
• Aligns with RHSC four strategic pillars
3
Data Collection in Kenya, Malawi and Mali
• Data collected in public and private sector facilities and pharmacies/drug shops
• Standardized questionnaire; tailored for each sector
• Convenience sample used with sites both in the capital city and in semi-urban and rural areas surrounding the capital
• Information collected on availability and price as well as basic information about quality
• Interviews with national stakeholders—Ministry of Health and regulatory personnel
4
Sample Size
Facility Type Mali(n=34)
Malawi(n=49)
Kenya(n=45)
Total(n=128)
Private 15 27 21 63
Public 12 11 17 40
Pharmacy / Drug shop
7 11 7 25
For the purposes of this assessment, “Public Sector” is defined as facilities and programs run by the government. “Private Sector” is defined as facilities run by national and international non-governmental organizations (NGOs), faith-based organizations, social marketing groups including social franchises, and
privately owned, for-profit clinics.
5
Availability of Pregnancy Tests
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Mali (n=34) Malawi (n=49) Kenya (n=45)
Typically available and day of Typically available, but not day of survey Not available
6
Pregnancy tests available at day of survey
% facilities with test Mali(n=29)
Malawi(n=40)
Kenya(n=38)
Total(n=107)
“Dip strip” urine test 97 95 100 97
Midstream urine test 7 5 5 6
Rapid blood test 0 5 0 2
Other 0 3 3 2
Note: 21 facilities were not administered this question due to either (1) not typically having urine pregnancy tests available, or (2) not having any in stock at the day of the survey. Facilities could have multiple different types of tests in stock.
7
Are Women Ever Sent Away to Buy Tests? (Public & private facilities only)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Mali(n=27)
Malawi(n=38)
Kenya(n=38)
Sometimes Never
Results from following question: “If there are either occasional stock-outs of pregnancy tests or if pregnancy tests are never available at this facility, are women ever instructed to purchase pregnancy tests elsewhere?
8
Price of ‘least expensive’ pregnancy test available in US dollars by facility type
*Mean calculated among facilities that reported charging for the test. Reflects the “least expensive” pregnancy test available at each facility
Mali(n=30)
Malawi(n=39)
Kenya(n=42)
Private mean* [range], US$ 1.99 [0.41-3.28] 0.95 [0.35-1.77] 1.94 [0.98-5.87]
sample size n=14 n=19 n=20
No charge for test (n=1) (n=2) (n=5)
Public mean* [range], US$ 1.72 [0.82-2.46] 0.35 [0.35-0.35] 1.86 [0.98-4.89]
sample size n=10 n=9 n=15
no charge for test (n=1) (n=8) (n=10)
Pharmacy / Drug shop
mean* [range], US$ 2.12 [1.15-2.46] 0.66 [0.35-0.88] 0.84 [0.49-1.96]
sample size n=6 n=11 n=7
no charge for test (n=0) (n=0) (n=0)
9
Reported access to pregnancy test by client type (public & private facilities only)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Mali (n=27) Malawi (n=38) Kenya (n=38)
Any client ANC clients FP Clients
“Q: Are pregnancy tests procured for family planning programs specifically? A: No.Q: Which programs are they procured for? A: They go for antenatal care to confirm pregnancy.”
-From interview with MOH official, Kenya
11
Awareness, availability and use of Pregnancy Checklist (public & private facilities only)
0%
10%
20%
30%
40%
50%
60%
70%
Mali(n=27)
Malawi(n=38)
Kenya(n=38)
Ever heard of checklist Copy of checklist at facility Providers typically use checklist
“[To rule out pregnancy,] providers typically would find out if the woman had menses or not. Because the Checklist is there, but how many have been trained?...How many have been caught up with? Typically it will be a menses history.”
-Interview with MOH official, Kenya
13
Ruling out Pregnancy in Non-Menstruating Women (public vs. private facilities)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Urine pregnancytest
Pregnancychecklist
Purchasepregnancy test off-
site
Patient history Physical exam
Private (n=63) Public (n=40)
14
Key Take-aways: Availability & Affordability
• Availability of pregnancy tests in facilities/pharmacies does not seem to be a key area of concern, although in Malawi and Kenya more than half of women are sometimes sent away to another site to purchase pregnancy tests
• Across the three countries, average price to consumers was 4-21 times the procurement price and the range was 4-59 times the procurement price (assuming a procurement price of US $0.10). High mark-ups observed across public, private and pharmacies
• Availability and use of Pregnancy Checklist low, particularly in Malawi and Mali
Quality & Supply Chain Considerations
Webinar
Tracey Brett
2
Methodology
• Interviews with MOH and National Regulatory personnel in Kenya, Malawi and Mali
• Review of pregnancy test samples from the field• Discussions with FP global procurers and supply chain stakeholders • Review of available information on international pregnancy test
quality standards.
3
International Quality StandardsCE MARKING: EUROPE• Pregnancy tests are classified as in vitro
diagnostic medical devices (IVD) subject to the European Directive 98/79/EC (IVDD).
• CE marking applies to a specific product or product family from the same manufacturer; therefore even if the manufacturer can show previous compliance this does not mean all products manufactured are ‘CE’ compliant.
• The importer is responsible for ensuring compliance and is often considered the “manufacturer” if marketing under its trademark/own label.
• A ‘Notified Body’—an independent organization that has been accredited to assess whether a product meets certain standards— should verify the design of the pregnancy test. Also, their compliance number should appear after the CE mark symbol on the product.
USFDA 510 (K) Clearance: US• Pregnancy tests are US FDA regulated as
Class II devices (moderate risk) and require 510(k) clearance prior to marketing.
• 510 K clearance applies to a specific product or product family from the same manufacturer
• FDA staff review a number of performance factors during 510(k) review – including precision, cut-off performance, linearity, interference, accuracy, and stability.
• FDA also evaluates inserts & box labelling • FDA conducts pre- and post-market reviews
of pregnancy test devices• FDA report from July 2013 in US market
indicates pregnancy test devices are accurate, with few false positive and/or false negative results generally reported
• No symbol displayed on product
4
Innovation Fund Project: Quality of Pregnancy Tests
Quality measure (%) Mali(n=28)
Malawi(n=37)
Kenya(n=38)
Total(n=103)
Valid date (not expired) 93 91 87 91
Written instructions in correct language
43 97 97 82
Illustrated instructions 100 100 97 99
CE mark appears 43 92 63 68
5
Samples from the field
• Found in a public sector facility • No international quality marks• Uncertain quality
• CE Marked – with notifying body number (0123= TUV SUD)
6
Quality and Procurement challenges• Concerns about fake or suspect CE-marked products entering
markets.• A number of samples collected through the Innovation Fund
project didn’t have any evidence of international quality assurance or they had misleading quality marks.
• Limited regulatory approval/oversight at national level.• Limited information and vis ibi l ity for procurers on the supply s ide:
vetting of potential suppliers, suppliers’ prior performance, methods to verify quality including pre- or post-shipment testing & lack of standardized specif ications ( labell ing , packaging, materials used)
• International procurement is spl it across a number of buyers –relatively ‘ low volume and low value’ which often translates into no dedicated resourcing for quality assurance, l imited sharing of information and pooling of resources.
“We cannot give you the data of how many [inaccurate results]. There is quite a bit that goes on. This is really an area of concern for us….
KMLTTB needs to be supported so we can also [undertake] post marketing surveillance….we need to be very vigilant.”
-Interview with Kenya Medical Laboratory Technicians and Technologist Board (KMLTTB) official, Kenya
8
Source of supply of pregnancy testsCountry Facility
typeSource of supply
knownSources of supply
Mali Public (n=10)
90% • Local NGO through social marketing/social franchising • Local pharmacy chains• Local wholesaler
Private(n=13)
77% • Local NGO through social marketing/social franchising • Local pharmacy chains
Malawi Public (n=9)
100% • MOH district hospital• MOH medical stores• Clinic network
Private(n=27)
78% • Local NGO through social marketing/social franchising • Local pharmacy chains• Local wholesaler
Kenya Public (n=15)
93% • Local wholesaler• MOH medical stores
Private(n=19)
68% • Central hospital• International NGO• Local NGO affiliate• Local wholesaler• Local pharmacy chain
9
National Essential Medicines Lists (EMLs)
Findings from the International Consortium for Emergency Contraception’s Innovation Fund project: • Pregnancy tests are not in the EML in Kenya, Malawi or Mali • The only countries in SSA, Asia and Latin America that
reference pregnancy tests in their EMLs are: o SSA: Cape Verde, Cote d'Ivoire, DRC, Madagascar,* Namibia,
Rwanda o Latin America and Caribbean: Guyana & Trinidad and Tobagoo East Asia & Pacific: Papua New Guinea
*Information about Madagascar EML provided by SHOPS project
Question for discussion: Should pregnancy tests be included in WHO and/or nat ional EML’s? Would their inclusion lead to an increased demand for pregnancy tests for FP and maternal health programs, and in turn, increase focus on qual i ty and supply chain issues?
10
Key Take-aways – Quality and Procurement Our assessment indicates that there is: • Lack of knowledge/confusion amongst consumers, providers,
importers, distributors, pharmacists and even in some cases regulatory personnel on internationally recognized quality standards for pregnancy tests ( including what existing standards mean and how they can be used to ensure that only quality pregnancy tests enter national markets)
• Lack of publical ly available protocol for pre- and post-shipment testing of batches
• Lack of strategy, focus and harmonization around pregnancy test procurement.
Question for discussion: • Would a more coordinated approach among donors and
implementing agencies help address challenges around pricing , quality and availabil ity?
January 2016
Applying the Market Shaping Primer to the Pregnancy Test Market
Market Shaping Primer framework can guide analysis of the pregnancy test market
1
Market Factor Status Notes
Affordability • High mark-ups observed across public and private clinics, and pharmacies. Average end-user markups of 4x-21x procurement cost observed in Kenya, Malawi and Mali.
• MOHs perceive tests to be too expensive • Low purchase price of US$0.10 per test possible from manufacturers
Availability • Variable availability in FP clinics because tests often not procured for large-scale distribution through FP programs
• Few countries include pregnancy testing as part of routine FP services• However, supply base is competitive with many manufacturers
Assured Quality • No consensus on quality indicators• Lack of independent, third-party verification
Appropriate Design • Pregnancy tests generally considered easy to use, and sometimes preferred to the pregnancy checklist
Awareness • Providers enthusiastic about using tests in situations where they cannot rule out pregnancy with checklist alone
WEAK
High markups and inconsistent availability appear to be key market shortcomings
STRONG
STRONG
MIXED
WEAK
Preliminary analysis
2
3
Initial analysis suggests market shaping may be able to address root causes
• Fragmented demand due to fractured procurement by NGOs, national governments, donors, and for-profit actors
• Possible inefficient ordering for different health areas: family planning and ANC orders not consolidated
• Little knowledge of how availability of pregnancy tests can affect access to FP or have other health benefits
• Potential procurers perceive pregnancy tests as expensive
• Unclear provider or end-user demand, including by market sector and across health areas
Preliminary analysis
3
• Current, uncoordinated demand for pregnancy tests from all sources likely represents small commercial opportunity for manufacturers
Consider market shaping options to address root causes in preg test market
4
Preg test market shaping: Potential to generate significant health impact, but need more data/analysis
5
• Create/consolidate demand forecasts and share with suppliers
• Coordinate or pool procurement of pregnancy tests₋ Across health areas ₋ Across procurers
• Bundle pregnancy test kits with FP methods for streamlined pricing and distribution
• Conduct market and programmatic research on critical assumptions to validate country-specific findings that pregnancy tests can increase FP access and possibly enable earlier ANC
Low awareness of potential health impact
Fractured procurement
• Inefficient ordering for FP and ANC programs
• Uncoordinated orders across procurers (donors, NGOs, MOHs, for-profit sector)
• Growing evidence that pregnancy test availability improves access to modern FP, especially LARCs
• Only ~1% of non-menstruating FP clients pregnant, but many unable to prove status
• Potential to encourage earlier access to ANC
• Cost of $0.06-0.10 (ex-factory)
• Average markups of 4x-21x in pharmacies/clinics, and high even in public sector
• MOHs perceive tests to be expensive despite price drops
• Tests often not procured for FP programs
• Few countries include pregnancy testing in routine FP services
• Conflicting data on clinic-level availability
High price to end-users
Uncertainavailability
Nearly half of new FP clients are not menstruating at clinic visit, and an estimated 17% of these women are denied FP services1
Zambia study showed FP clinics with pregnancy tests 4x less likely to deny a woman FP services; Madagascar project showed pregnancy tests increased hormonal contraceptive access by >20% per month2
Market Shortcomings Root Causes Intervention Options
Notes: 1. FHI360, Lancet Global Health Blog (February 2015). 2. “Providing free pregnancy test kits to community health workers increases distribution of contraceptives: results from an impact evaluation in Madagascar.” Contraception 93 (2016) 44–51. Acronyms: Antenatal care (ANC); Family planning (FP); Long-acting, reversible contraceptive (LARC); Ministry of Health (MOH); Non-governmental organization (NGO).
Preliminary analysis